Blood DonorsC-CADNCT04783077
Community-Based Communication Approaches for Blood Donation in Ghana
A study testing WhatsApp and Docudrama in people with Blood Donors, run by University of Minnesota at 1 site in Ghana.
Trial summary
DESIGN This pilot study utilizes a mixed-methods approach to develop a novel docu- drama communication strategy, design WhatsApp intervention, evaluate the feasibility of a larger pragmatic randomized controlled trial (RCT) of the two communication strategies and assess acceptability of the communication strategies… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Blood Donors
- What is being tested?
- WhatsApp and Docudrama
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteGhana
- Study dates
- 2 Nov 2021to 25 Sep 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least 18 years-old
- First-time whole blood donor with the SZBC of the NBSG
- Eligible to donate again
- Consent to participate
- Understands one of English, Twi, or Ga
- Have a smart phone
- Have, or be willing to sign up for an active WhatsApp account
Who cannot join
- History of more than one lifetime whole blood donation (with any blood centre)
Trial locations and contacts
1 site in 1 country.
About this study
DESIGN This pilot study utilizes a mixed-methods approach to develop a novel docu- drama communication strategy, design WhatsApp intervention, evaluate the feasibility of a larger pragmatic randomized controlled trial (RCT) of the two communication strategies and assess acceptability of the communication strategies aimed to increase blood donation among first-time blood donors within the catchment areas of the Southern Zonal Blood Centre (SZBC) in Ghana. In sequence, this pilot study and larger RCT are grounded in the PRECEDE-PROCEED implementation science framework. The pilot study has four components: 1) a qualitative component will be used to design a docu-drama, 2) key informant interviews to guide intervention development, 3) a simultaneous randomized pilot trial will evaluate the feasibility of the larger trial design of communication interventions using WhatsApp compared to control, and 4) a final mixed- methods (quantitative survey and focus groups) assessment of participant views of acceptability, effectiveness, feasibility and cultural appropriateness of the two proposed communication interventions.
OBJECTIVES The three objectives of this pilot study are the careful design of a novel docu- drama communication intervention and WhatsApp intervention, evaluation of the feasibility of a larger RCT of communication strategies, and assessment of participant views of the two proposed communication interventions and control among first time blood donors within the catchment areas of the SZBC.
Read more
For the purposes of registration for clinicaltrials.gov only the randomized pilot trial communication interventions using WhatsApp compared to control is reported.
The planned sample size for the pilot RCT is n=128 first-time blood donors.
The study population for the pilot RCT is first-time voluntary non-remunerated blood donors (VNRBD) and family/replacement blood donors (FRD) from the SZBC catchment area.
REGIMEN WhatsApp: Participants assigned to the WhatsApp group will receive weekly messages developed by communication specialists aimed to motivate blood donation, be encouraged to discuss their blood donation experiences, and share their own motivations for donating blood in a moderated, closed group over a six-month duration. The moderator will provide guidelines on acceptable use of WhatsApp in the group, including images they can or cannot share. Participants will also receive standard NBSG communications for first-time donors.
Control: Participants in this group will receive the standard NBSG communications for first-time donors: 1) a thank you phone call and 2) and a reminder phone call two-weeks prior to the second blood donation eligibility. The second blood donation eligibility is four months after the first donation.
- Conditions
- Blood Donors
- Being tested
- WhatsApp, Control, Docudrama
- Keywords
- Blood donation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WhatsAppBehavioural
Participants assigned to the WhatsApp group will receive weekly messages developed by communication specialists aimed to motivate blood donation, be encouraged to discuss their blood donation experiences, and share their own motivations for donating blood in a moderated, closed group over a six-month duration. The moderator will provide guidelines on acceptable use of WhatsApp in the group, including images they can or cannot share. Participants will also receive standard NBSG communications for first-time donors.
ControlBehavioural
Participants in this group will receive the standard NBSG communications for first-time donors: 1) a thank you phone call and 2) and a reminder phone call two-weeks prior to the second blood donation eligibility. The second blood donation eligibility is four months after the first donation.
DocudramaBehavioural
Participants will be exposed to a document-drama related to blood donation.
| Study group | Role | What they receive |
|---|---|---|
| FRD Control | Active comparator | Not described Receives: Behavioral: Control |
| VNRBD Control | Active comparator | Not described Receives: Behavioral: Control |
| FRD WhatsApp | Experimental | Not described Receives: Behavioral: WhatsApp |
| VNRBD WhatsApp | Experimental | Not described Receives: Behavioral: WhatsApp |
| Docudrama | Experimental | Not described Receives: Behavioral: Docudrama |
What is being measured
The primary outcome is the main question the study is designed to answer.
Donation Attempt
Blood donation attempt at any time during follow-up. The planned follow-up (i.e., final assessment) was at 6-months and 2 weeks from randomization. However, the local protocol IRB approval lapsed between 25 April 2022 and 23 May 2022 during which time participants were unable to receive WhatsApp messaging. In response, the final follow-up window was extended by 34 days for all participants, so the participants in the WhatsApp arm would receive all planned messages.
Measured: 6 Months and 34 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2021
- Study start2 Nov 2021
- Primary completion25 Sep 2022
- Study completion25 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Blood DonorsStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A pilot stratified randomized control trials of WhatsApp compared to control and docudrama (before/after) among first time donors.
- Masking
- None (open label)
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), National Blood Service Ghana, University of Ghana, Syracuse University, Liverpool School of Tropical Medicine
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04783077
- Sponsor's protocol ID
- 326045
- Other IDs
- UG3HL151599
- Acronym
- C-CAD
- Status last verified
- Jan 2024
- First submitted
- 26 Feb 2021
- Last updated
- 10 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The BLOODSAFE project is committed to quickly sharing results and data. Papers will be submitted summarizing the primary results of the BLOODSAFE studies once the analysis is complete. These results will be published in major scientific journals and presented at scientific meetings.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community-Based Communication Approaches for Blood Donation in Ghana
- ClinicalTrials.gov ID
- NCT04783077
- Acronym / sponsor ID
- C-CAD / 326045
- Conditions
- Blood Donors
- Keywords
- Blood donation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), National Blood Service Ghana, University of Ghana, Syracuse University, Liverpool School of Tropical Medicine
- Study start
- 2 Nov 2021 (actual)
- Primary completion
- 25 Sep 2022 (actual)
- Study completion
- 25 Sep 2023 (actual)
- First posted
- 5 Mar 2021 (actual)
- Results
- Posted 10 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
DESIGN This pilot study utilizes a mixed-methods approach to develop a novel docu- drama communication strategy, design WhatsApp intervention, evaluate the feasibility of a larger pragmatic randomized controlled trial (RCT) of the two communication strategies and assess acceptability of the communication strategies aimed to increase blood donation among first-time blood donors within the catchment areas of the Southern Zonal Blood Centre (SZBC) in Ghana. In sequence, this pilot study and larger RCT are grounded in the PRECEDE-PROCEED implementation science framework. The pilot study has four components: 1) a qualitative component will be used to design a docu-drama, 2) key informant interviews to guide intervention development, 3) a simultaneous randomized pilot trial will evaluate the feasibility of the larger trial design of communication interventions using WhatsApp compared to control, and 4) a final mixed- methods (quantitative survey and focus groups) assessment of participant views of acceptability, effectiveness, feasibility and cultural appropriateness of the two proposed communication interventions.
OBJECTIVES The three objectives of this pilot study are the careful design of a novel docu- drama communication intervention and WhatsApp intervention, evaluation of the feasibility of a larger RCT of communication strategies, and assessment of participant views of the two proposed communication interventions and control among first time blood donors within the catchment areas of the SZBC.
For the purposes of registration for clinicaltrials.gov only the randomized pilot trial communication interventions using WhatsApp compared to control is reported.
The planned sample size for the pilot RCT is n=128 first-time blood donors.
The study population for the pilot RCT is first-time voluntary non-remunerated blood donors (VNRBD) and family/replacement blood donors (FRD) from the SZBC catchment area.
REGIMEN WhatsApp: Participants assigned to the WhatsApp group will receive weekly messages developed by communication specialists aimed to motivate blood donation, be encouraged to discuss their blood donation experiences, and share their own motivations for donating blood in a moderated, closed group over a six-month duration. The moderator will provide guidelines on acceptable use of WhatsApp in the group, including images they can or cannot share. Participants will also receive standard NBSG communications for first-time donors.
Control: Participants in this group will receive the standard NBSG communications for first-time donors: 1) a thank you phone call and 2) and a reminder phone call two-weeks prior to the second blood donation eligibility. The second blood donation eligibility is four months after the first donation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- A pilot stratified randomized control trials of WhatsApp compared to control and docudrama (before/after) among first time donors.
| Arm | Type | Receives |
|---|---|---|
| FRD Control | Active comparator | Behavioral: Control |
| VNRBD Control | Active comparator | Behavioral: Control |
| FRD WhatsApp | Experimental | Behavioral: WhatsApp |
| VNRBD WhatsApp | Experimental | Behavioral: WhatsApp |
| Docudrama | Experimental | Behavioral: Docudrama |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- At least 18 years-old
- First-time whole blood donor with the SZBC of the NBSG
- Eligible to donate again
- Consent to participate
- Understands one of English, Twi, or Ga
Key exclusion criteria (1 listed)
- History of more than one lifetime whole blood donation (with any blood centre)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WhatsAppParticipants assigned to the WhatsApp group will receive weekly messages developed by communication specialists aimed to motivate blood donation, be encouraged to discuss their blood donation experiences, and share their own motivations for donating blood in a moderated, closed group over a six-month duration. The moderator will provide guidelines on acceptable use of WhatsApp in the group, including images they can or cannot share. Participants will also receive standard NBSG communications for first-time donors. | Behavioural | FRD WhatsApp, VNRBD WhatsApp |
| ControlParticipants in this group will receive the standard NBSG communications for first-time donors: 1) a thank you phone call and 2) and a reminder phone call two-weeks prior to the second blood donation eligibility. The second blood donation eligibility is four months after the first donation. | Behavioural | FRD Control, VNRBD Control |
| DocudramaParticipants will be exposed to a document-drama related to blood donation. | Behavioural | Docudrama |
Primary outcome
Donation Attempt
Time frame: 6 Months and 34 days
Blood donation attempt at any time during follow-up. The planned follow-up (i.e., final assessment) was at 6-months and 2 weeks from randomization. However, the local protocol IRB approval lapsed between 25 April 2022 and 23 May 2022 during which time participants were unable to receive WhatsApp messaging. In response, the final follow-up window was extended by 34 days for all participants, so the participants in the WhatsApp arm would receive all planned messages.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. The BLOODSAFE project is committed to quickly sharing results and data. Papers will be submitted summarizing the primary results of the BLOODSAFE studies once the analysis is complete. These results will be published in major scientific journals and presented at scientific meetings.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WhatsApp and Docudrama in people with Blood Donors, run by University of Minnesota at 1 site in Ghana.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ghana. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Donation Attempt (time frame: 6 Months and 34 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2024.